FDA recall: an earwax-removal product assayed at roughly a tenth of expectation — about 0.6 percent against an expected 6 to 7 percent (Bell Pharmaceuticals)
A product sold as carbamide peroxide 6.5 percent was recalled for low pH and a significantly reduced assay, reported as about 0.6 percent against an expected 6 to 7 percent. The quantity is 31,094 units, distributed nationwide.
Recall overview (primary data)
- ClassificationClass II
- Product typeDrug
- Recalling firmBell Pharmaceuticals, Inc
- ReasonSubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
- DistributionU.S Nationwide
- Recall initiated2026-06-25
Key points
- A product sold as carbamide peroxide 6.5 percent was recalled after assay came in at about 0.6 percent against an expected 6 to 7 percent.
- Low pH is recorded alongside, pointing to degradation of the active ingredient or to the product not having been made as designed.
- The quantity is 31,094 units distributed nationwide; the recall was firm-initiated on 2026-06-25.
- Where almost no active ingredient is present, the effect appears as the product not working, which a user cannot tell apart from a severe condition.
- Across the 1,408 records this site holds as of 2026-08-31, drugs are 14 Class I against 274 Class II — 95 percent Class II — while food is close to even at 168 and 173.
- Among the FDA recall records this site holds as of 2026-09-01, drugs split 14 Class I to 274 Class II, food 168 to 173, and devices 137 to 642.
1A record that states the numbers
Recall records usually stop at a phrase such as below specification. This one differs, stating an assay of about 0.6 percent against an expected 6 to 7 percent. A gap of more than tenfold is not a matter of slipping slightly outside a limit. Low pH is cited alongside, pointing to the active ingredient having degraded, or to the product never having been made as designed.
Records that state figures this concretely are uncommon, and that makes what happened easier to read.
2Danger in the form of not working
Carbamide peroxide is used to soften earwax. Where almost none of the active ingredient is present, the effect appears less as direct harm than as the expected result failing to arrive. From the user side, whether it is not working or the condition is severe cannot be told apart.
That the classification is Class II appears to reflect that character, though it remains the case that not working is itself a route to delaying the response that was needed.
3Drug recalls are 95 percent Class II
Splitting the 1,408 FDA recall records this site holds as of 2026-08-31 by product type and classification, drugs run 14 Class I against 274 Class II, so Class II accounts for 95 percent.
Food, by contrast, is close to even at 168 Class I and 173 Class II, while devices are 137 Class I and 642 Class II. Drug recalls are centred less on the type that causes immediate serious harm than on departures from specification such as potency and impurities. Records citing subpotency number 36 among the 1,408.
| Product type | Class I | Class II |
|---|---|---|
| Drugs | 14 | 274 |
| Food | 168 | 173 |
| Devices | 137 | 642 |
Why it matters
Product defects divide into those that cause harm and those that fail to do what was expected. The second is harder for users to register as an anomaly and less likely to be reported. A case where basic indicators such as assay and pH ran far outside limits raises the question of when pre-shipment testing occurred and how large a deviation the design was capable of catching.
FAQ
How far below was it?
Is merely not working safe?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: D-0686-2026